Drug Type Small molecule drug |
Synonyms Orebatinib, Oribatinib, 奥瑞巴替尼 + [15] |
Target |
Action inhibitors |
Mechanism Bcr-Abl T315I inhibitors(BCR-ABL T315I mutation inhibitors), c-Kit inhibitors(Stem cell growth factor receptor inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date China (24 Nov 2021), |
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China) |
Molecular FormulaC31H35F3N6O7S2 |
InChIKeyLEVIGHXVOVROGW-UHFFFAOYSA-N |
CAS Registry1421783-64-3 |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Aggressive-Phase Chronic Myelocytic Leukemia | China | 24 Nov 2021 | |
| Chronic phase chronic myeloid leukemia | China | 24 Nov 2021 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| SDH-deficient Gastrointestinal Stromal Tumors | Phase 3 | China | 11 Nov 2024 | |
| SDH-deficient Gastrointestinal Stromal Tumors | Phase 3 | China | 11 Nov 2024 | |
| Philadelphia chromosome positive chronic myelogenous leukemia | Phase 3 | United States | 05 Feb 2024 | |
| Philadelphia chromosome positive chronic myelogenous leukemia | Phase 3 | Japan | 05 Feb 2024 | |
| Philadelphia chromosome positive chronic myelogenous leukemia | Phase 3 | Australia | 05 Feb 2024 | |
| Philadelphia chromosome positive chronic myelogenous leukemia | Phase 3 | Belgium | 05 Feb 2024 | |
| Philadelphia chromosome positive chronic myelogenous leukemia | Phase 3 | Canada | 05 Feb 2024 | |
| Philadelphia chromosome positive chronic myelogenous leukemia | Phase 3 | France | 05 Feb 2024 | |
| Philadelphia chromosome positive chronic myelogenous leukemia | Phase 3 | Germany | 05 Feb 2024 | |
| Philadelphia chromosome positive chronic myelogenous leukemia | Phase 3 | India | 05 Feb 2024 |
Not Applicable | 253 | (Philadelphia chromosome-positive acute lymphoblastic leukemia) | apsadezgxv(xbdcxoqrqc) = wawatupblb fcwauckbtq (evgqmereau, 67.0 - 96.0) View more | Positive | 29 May 2026 | ||
Phase 1 | 9 | (R/R Ph+ BCP-ALL or CML-LBP) | agqvuyazki(whzwnrnbyz) = Four patients experienced grade 3 AEs related to olverembatinib, including increased lipase, neutropenia, thrombocytopenia, and pancreatitis. kwmewwgqrf (dlfyrevkkk ) View more | Positive | 29 May 2026 | ||
Phase 3 | Chronic phase chronic myeloid leukemia T315I mutation | 270 | utyobaftkf(shnyssdjtb) = ssnfmrnwha zszvpxhneg (zlflifwimg ) | Positive | 29 May 2026 | ||
(T315I mutation) | ttjhatwafu(alhswisnff) = ntdhytfxgo qvymkdarni (tkqplilnoy ) | ||||||
Not Applicable | 105 | kxhbpzqsze(ivhvmepowu) = qpcxgggebr uxcjysejeq (tsastmxrgs ) View more | Positive | 12 May 2026 | |||
Original TKI therapy | kxhbpzqsze(ivhvmepowu) = ewyxigozga uxcjysejeq (tsastmxrgs ) View more | ||||||
Not Applicable | 60 | vqqzzlanbi(erqaoplbsl) = Non-hematological toxicity with an incidence of more than 10 % included 24(45%) pigmented nevus, 10 (13.9%) infections, 6(10%) rash, 6(10%) myoarthritis. 4(6.7%) patients developed cardia-cerebrovascular events(1 angina, 1 cerebral infarction and 2 arrhythmias). xxgnumyris (clwtjzflie ) | Positive | 12 May 2026 | |||
Phase 3 | 333 | jljwkyknmb(utxripczpb) = mfckgdabei htthjzeswc (wpwmivkybg ) | Positive | 12 May 2026 | |||
jljwkyknmb(csixgvijkp) = ueiwpepaiu whqreviczr (datuqgktdk ) View more | |||||||
Not Applicable | 167 | Olverembatinib therapy | yptgcbcccf(bkrardiusm) = cdybsrcelr ppzkqugejr (tokzrajgjh ) View more | Positive | 06 Dec 2025 | ||
Not Applicable | 64 | iygjncxxko(azflijptej) = Treatment-related adverse events in olverembatinib cohort 52.4% (11/21) of patients. Six (28.6%) developed grade 3/4 neutropenia. Cardiovascular Events were observed in two patients, including deep vein thrombosis (n=1) and pericardial effusion (n=1). rpytarkjqn (sgkkbahsns ) View more | Positive | 06 Dec 2025 | |||
1/2G-TKI | |||||||
Not Applicable | 63 | izuhoaqcko(fkckzwmyuz) = nezdeivzao xnmzrdpnpe (ghtqmpwdop ) View more | Positive | 06 Dec 2025 | |||
original TKI therapy | izuhoaqcko(fkckzwmyuz) = exivddfxbb xnmzrdpnpe (ghtqmpwdop ) View more | ||||||
Phase 1 | SDH-deficient Gastrointestinal Stromal Tumors SDH deficient | 66 | (TKI-failed, evaluable) | hdilfhcbxm(jzoyprldey) = kwkxpzsnio rvzwtnothh (yzmptibdzj, 9 - 43.7) View more | Positive | 04 Nov 2025 |





